Overweight and ObesityCHO-EXNCT06381908
The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity
A study testing Calorie-restriction with low carbohydrate and Calorie-restriction with moderate carbohydrate in people with Overweight and Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity, metabolism and metabolic health indicators will be measured in a randomized parallel group design. Forty overweight (BMI 25-30) and relatively inactive women (20-35 of age) will be included. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Calorie-restriction with low carbohydrate and Calorie-restriction with moderate carbohydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-35
- BMI: 25-30
Who cannot join
- Irregular menstruation within the last 6 months (shorter end 24 days or longer end 35 days cycle)
- Injuries / pain in the lower body, which prevents participation in intense cycling
- Medication consumption that may affect primary outcome measures.
- Smoking
- Pregnancy
- Systematic physical activity more than 2 hours per week
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Section for Sport Science, Department of Public Health, Aarhus University
Aarhus C, 8000
About this study
Official title: The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity and Health in Overweight Women
The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity, metabolism and metabolic health indicators will be measured in a randomized parallel group design. Forty overweight (BMI 25-30) and relatively inactive women (20-35 of age) will be included. These will be randomized into one of two experimental groups both receiving a calorie-restricted diet (-1000 kcal) combined with either low carbohydrate availability or moderate carbohydrate availability across a 10 day period. Laboratory-based physical capacity tests and blood and muscle sampling will be performed before and after the intervention. In addition, an additional follow-up test day will be performed after continuing the diet for another 48 h and then standardizing the pre-testing carbohydrate availability before repeating the tests of physical capacity.
Read the detailed description
Overweight (BMI 25-30), but healthy premenopausal women aged 20-35 years (n=40) will be included in the trial, which is structured as a randomized, parallel group design where participants are randomized to either consume a hypocaloric diet (-1000 kcal) with concurrent carbohydrate restriction (low carbohydrate, L-CHO, n=20) or a similar hypocaloric diet with moderate carbohydrate availability (moderate carbohydrate, M-CHO, n=20). The trial will be single-blinded since it might be transparent to the participants which diet they are consuming, whereas the test personnel collecting and processing test results will be blinded to diet allocation. Diet handling will be managed by specific individuals in the research group who do not partake in executing the physical capacity tests. Additionally, the direction of the trial's primary hypothesis will not be disclosed to the participants to avoid creating preconceived expectations about the effects.
After an initial screening interview and two familiarization visits, participants will complete the intervention period consisting of 10 days with the allocated diet manipulation with preceding and subsequent test days with a series of tests. The tests before and after each test period include measurements of the participants' physical capacity level and energy metabolism in the laboratory as well as blood and muscle sampling. In addition, resting metabolism and body composition will be measured. During each test period, participants' habitual activity level will be monitored with an accelerometer attached to the wrist (Axivity). There will also be monitoring of the activity level with an accelerometer in a 7-day cycle before the start of the trial as a baseline measurement.
Similarly, a glucose monitor will be placed on the upper arm for continuous glucose readings via a Freestyle Libre2 sensor during the trial period.
- Conditions
- Overweight and Obesity
- Being tested
- Calorie-restriction with low carbohydrate, Calorie-restriction with moderate carbohydrate
- Keywords
- Physical activity, Metabolism, Physical capacity, Macronutrients, Carbohydrate, Diet
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie-restriction with low carbohydrateOther
Calorie-restriction and low carbohydrate availability
Calorie-restriction with moderate carbohydrateOther
Calorie-restriction and moderate carbohydrate availability
| Study group | Role | What they receive |
|---|---|---|
| Low-carbohydrate calorie-restriction | Active comparator | Minimum of 3 g carbohydrate/kg body weight/day and a ~1000 kcal calorie restriction Receives: Other: Calorie-restriction with low carbohydrate |
| Moderate-carbohydrate calorie-restriction | Experimental | Maximum of 1 g carbohydrate/kg body weight/day and a ~1000 kcal calorie restriction Receives: Other: Calorie-restriction with moderate carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exhaustion
Time to exhaustion at 85% VO2max
Measured: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Sprint performance
Peak and mean 15-s sprint performance
Measured: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Exercise tolerance
Ratings of perceived exertion (Borg scale) during standardized-intensity exercise from 6 (lowest exertion) to 20 (highest exertion)
Measured: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Muscle glycogen levels
Muscle glycogen levels obtained from biopsy sample
Measured: Pre and post (day 11 of the intervention)
Secondary outcomes (7)
Physical activity level
Measured with accelerometer during the intervention
Measured: During the intervention (days 1 to 11 of the intervention)
Maximal fat oxidation capacity
Maximal fat oxidation measured in the laboratory
Measured: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Muscle metabolic enzyme activity
Activity of key enzymes involved in carbohydrate and fat metabolism
Measured: Pre and post (day 11 of the intervention)
Blood lipid profile
High-density lipoproteins, low-density lipoproteins, very-low-density lipoproteins, cholesterol, free fatty acids and triglycerides
Measured: Pre and post (day 11 of the intervention)
Continuous glucose levels
Glucose levels measured continuously across the trial + during exercise tests
Measured: 14 days from the day before the intervention, throughout the intervention (days 1 to 11) and 2 days after the intervention (follow-up)
Fasting blood glucose and insulin
Insulin sensitivity (Homa 2 IR)
Measured: Pre and post (day 11 of the intervention)
Long-term glycemic control (HbAc1)
Measured from fasting blood
Measured: Pre and post (day 11 of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Apr 2024
- Primary completion15 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is performed as a randomized single-blinded parallel group design. Randomization is performed into two groups using minimization based on a predetermined estimated VO2max middle value of 30.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, University Ghent
- Responsible party
- Principal investigator, Mette Hansen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381908
- Sponsor's protocol ID
- 1-10-72-19-24
- Acronym
- CHO-EX
- Status last verified
- Feb 2026
- First submitted
- 5 Apr 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity and Health in Overweight Women
- ClinicalTrials.gov ID
- NCT06381908
- Acronym / sponsor ID
- CHO-EX / 1-10-72-19-24
- Conditions
- Overweight and Obesity
- Keywords
- Physical activity, Metabolism, Physical capacity, Macronutrients, Carbohydrate, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Southern Denmark, University Ghent
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity, metabolism and metabolic health indicators will be measured in a randomized parallel group design. Forty overweight (BMI 25-30) and relatively inactive women (20-35 of age) will be included. These will be randomized into one of two experimental groups both receiving a calorie-restricted diet (-1000 kcal) combined with either low carbohydrate availability or moderate carbohydrate availability across a 10 day period. Laboratory-based physical capacity tests and blood and muscle sampling will be performed before and after the intervention. In addition, an additional follow-up test day will be performed after continuing the diet for another 48 h and then standardizing the pre-testing carbohydrate availability before repeating the tests of physical capacity.
Detailed description
Overweight (BMI 25-30), but healthy premenopausal women aged 20-35 years (n=40) will be included in the trial, which is structured as a randomized, parallel group design where participants are randomized to either consume a hypocaloric diet (-1000 kcal) with concurrent carbohydrate restriction (low carbohydrate, L-CHO, n=20) or a similar hypocaloric diet with moderate carbohydrate availability (moderate carbohydrate, M-CHO, n=20). The trial will be single-blinded since it might be transparent to the participants which diet they are consuming, whereas the test personnel collecting and processing test results will be blinded to diet allocation. Diet handling will be managed by specific individuals in the research group who do not partake in executing the physical capacity tests. Additionally, the direction of the trial's primary hypothesis will not be disclosed to the participants to avoid creating preconceived expectations about the effects.
After an initial screening interview and two familiarization visits, participants will complete the intervention period consisting of 10 days with the allocated diet manipulation with preceding and subsequent test days with a series of tests. The tests before and after each test period include measurements of the participants' physical capacity level and energy metabolism in the laboratory as well as blood and muscle sampling. In addition, resting metabolism and body composition will be measured. During each test period, participants' habitual activity level will be monitored with an accelerometer attached to the wrist (Axivity). There will also be monitoring of the activity level with an accelerometer in a 7-day cycle before the start of the trial as a baseline measurement.
Similarly, a glucose monitor will be placed on the upper arm for continuous glucose readings via a Freestyle Libre2 sensor during the trial period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is performed as a randomized single-blinded parallel group design. Randomization is performed into two groups using minimization based on a predetermined estimated VO2max middle value of 30.
| Arm | Type | Receives |
|---|---|---|
| Low-carbohydrate calorie-restriction | Active comparator | Other: Calorie-restriction with low carbohydrateMinimum of 3 g carbohydrate/kg body weight/day and a ~1000 kcal calorie restriction |
| Moderate-carbohydrate calorie-restriction | Experimental | Other: Calorie-restriction with moderate carbohydrateMaximum of 1 g carbohydrate/kg body weight/day and a ~1000 kcal calorie restriction |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 20-35
- BMI: 25-30
Key exclusion criteria (6 listed)
- Irregular menstruation within the last 6 months (shorter end 24 days or longer end 35 days cycle)
- Injuries / pain in the lower body, which prevents participation in intense cycling
- Medication consumption that may affect primary outcome measures.
- Smoking
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calorie-restriction with low carbohydrateCalorie-restriction and low carbohydrate availability | Other | Low-carbohydrate calorie-restriction |
| Calorie-restriction with moderate carbohydrateCalorie-restriction and moderate carbohydrate availability | Other | Moderate-carbohydrate calorie-restriction |
Primary outcome
Time to exhaustion
Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Time to exhaustion at 85% VO2max
Sprint performance
Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Peak and mean 15-s sprint performance
Exercise tolerance
Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Ratings of perceived exertion (Borg scale) during standardized-intensity exercise from 6 (lowest exertion) to 20 (highest exertion)
Muscle glycogen levels
Time frame: Pre and post (day 11 of the intervention)
Muscle glycogen levels obtained from biopsy sample
7 secondary outcomes
Physical activity level
Time frame: During the intervention (days 1 to 11 of the intervention)
Maximal fat oxidation capacity
Time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)
Muscle metabolic enzyme activity
Time frame: Pre and post (day 11 of the intervention)
Blood lipid profile
Time frame: Pre and post (day 11 of the intervention)
Continuous glucose levels
Time frame: 14 days from the day before the intervention, throughout the intervention (days 1 to 11) and 2 days after the intervention (follow-up)
Fasting blood glucose and insulin
Time frame: Pre and post (day 11 of the intervention)
Long-term glycemic control (HbAc1)
Time frame: Pre and post (day 11 of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie-restriction with low carbohydrate and Calorie-restriction with moderate carbohydrate in people with Overweight and Obesity, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to exhaustion (time frame: Pre, post (day 11 of the intervention) and follow-up (day 2 after the post measurement)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.